Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124750923 | 12475092 | 3 | F | 20160501 | 20160816 | 20160617 | 20160823 | EXP | JP-009507513-1606JPN005763 | MERCK | 12.00 | YR | M | Y | 48.00000 | KG | 20160823 | MD | JP | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124750923 | 12475092 | 1 | PS | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 5 MG, ONCE A DAY | 20830 | 5 | MG | CHEWABLE TABLET | QD | ||||||
| 124750923 | 12475092 | 2 | C | LORATADINE. | LORATADINE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 124750923 | 12475092 | 3 | C | CALONAL | ACETAMINOPHEN | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 124750923 | 12475092 | 4 | C | MIYA-BM | CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 | 1 | Oral | UNK | 0 | ||||||||||
| 124750923 | 12475092 | 5 | C | SAWACILLIN | AMOXICILLIN | 1 | Oral | UNK | 0 | ||||||||||
| 124750923 | 12475092 | 6 | C | MIDAZOLAM | MIDAZOLAMMIDAZOLAM HYDROCHLORIDE | 1 | Parenteral | UNK | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124750923 | 12475092 | 1 | Rhinitis allergic |
| 124750923 | 12475092 | 2 | Rhinitis |
| 124750923 | 12475092 | 3 | Pyrexia |
| 124750923 | 12475092 | 4 | Abdominal pain |
| 124750923 | 12475092 | 5 | Pyrexia |
| 124750923 | 12475092 | 6 | Generalised tonic-clonic seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124750923 | 12475092 | OT |
| 124750923 | 12475092 | LT |
| 124750923 | 12475092 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124750923 | 12475092 | Abdominal pain | |
| 124750923 | 12475092 | Generalised tonic-clonic seizure | |
| 124750923 | 12475092 | Hepatitis fulminant | |
| 124750923 | 12475092 | Malaise | |
| 124750923 | 12475092 | Nausea | |
| 124750923 | 12475092 | Pyrexia | |
| 124750923 | 12475092 | Rash |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 124750923 | 12475092 | 1 | 201602 | 20160504 | 0 | |
| 124750923 | 12475092 | 2 | 201602 | 20160504 | 0 | |
| 124750923 | 12475092 | 3 | 20160502 | 0 | ||
| 124750923 | 12475092 | 4 | 20160502 | 0 | ||
| 124750923 | 12475092 | 5 | 20160502 | 0 | ||
| 124750923 | 12475092 | 6 | 20160505 | 20160505 | 0 |